8 devices · 2 companies · 2018 to 2025
GE Healthcare: AI-enabled devices on FDA's list
8 devices from GE Healthcare, 2018 to 2025, from 2 companies across 5 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 8 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from GE Healthcare
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Senographe Pristina 3DP130020/S005 · PMA | Radiology | OTE | database entry | |
| MR Contour DLK242925 · 510(k) | Radiology | QKB | database entry | |
| Precision DLK223212 · 510(k) | Radiology | KPS | database entry | |
| Xeleris V Processing and Review SystemK221680 · 510(k) | Radiology | LLZ | database entry | |
| Voluson P6, Voluson P8K213689 · 510(k) | Radiology | IYN | database entry | |
| Voluson S6, Voluson S8, Voluson S8t, Voluson S10K213642 · 510(k) | Radiology | IYN | database entry | |
| Xeleris V Processing and Review SystemsK201103 · 510(k) | Radiology | LLZ | database entry | |
| Centricity Universal ViewerK182419 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.